ORPH.L Regulatory News (ORPH)

21 December 2021

Open Orphan plc

("Open Orphan" or the "Company")

£5m Influenza human challenge study contract win

Open Orphan plc (AIM: ORPH), a rapidly growing specialist contract research organisation (CRO) and world leader in vaccine and antiviral testing using human challenge clinical trials, announces that hVIVO, a subsidiary of Open Orphan plc, has signed a £5m influenza human challenge study contract with a biotech company developing an antiviral drug for protection against respiratory viral infections.

The study, which is expected to commence in H2 2022, will test and assess the efficacy of a single dosing regimen of the client's antiviral drug, with healthy adult volunteers, using the hVIVO Influenza human challenge study model. Conducted at hVIVO's state-of-the-art facilities in London, Open Orphan expects the majority of revenues to be recognised in 2022.

Respiratory tract infections are infections of parts of the body involved in breathing, such as the sinuses, throat, airways or lungs and are often caused by viruses such as influenza. Seasonal influenza causes significant morbidity and mortality each year and a pandemic influenza continues to pose a worldwide threat. Influenza is a serious global health threat with an estimated 1 billion cases per year, 3-5 million severe cases and 290,000 - 650,000 deaths per year. Healthy volunteer human challenge studies of wild-type influenza play a major role in the development of vaccines and therapeutics against influenza.

hVIVO has been studying influenza for over 20 years and conducting influenza human challenge studies with its flu disease models for more than 15 years. hVIVO has conducted numerous flu challenge studies for a range of industry, governmental and academic clients, making its models the most well-used commercial flu disease models available on the market. hVIVO also has expertise in safely conducting challenge studies across a range of respiratory viruses, including various strains of Influenza, Respiratory Syncytial Virus (RSV) and human Rhinovirus HRV (common cold virus), malaria, and asthma. In October 2020, this expanded to include the SARS-CoV-2 virus.

Cathal Friel, Executive Chairman of Open Orphan, said: "We are delighted to be working with this biotech client to assess the efficacy of their antiviral product which has the potential to be an important treatment against respiratory viral infections, using the hVIVO Influenza human challenge study model.

"We have now signed contracts for 95% of our 2022 forecasted revenues. This is the fourth Influenza human challenge study that we have signed in 2021 and coupled with the contract wins that we have seen in other disease areas, this further underlines the growing interest in respiratory and infectious diseases within the pharmaceutical and biotechnology industries, which we expect to continue over the coming years.

"Additionally, the continued damaging effects of the COVID-19 pandemic have underlined the need for increased pandemic preparedness in relation to other potential pandemic infectious diseases, such as influenza. Our expertise in testing vaccines and antivirals against our portfolio of infectious disease human challenge models will be important in ensuring we are prepared for the next, potentially more dangerous pandemic disease."

The information contained within this announcement is deemed by the Company to constitute inside information as stipulated under the Market Abuse Regulations (EU) No. 596/2014 (as implemented into English law) ("MAR"). With the publication of this announcement via a Regulatory Information Service, this inside information is now considered to be in the public domain.

Interested in becoming a volunteer?

hVIVO recruits many of its volunteers for its challenge study clinical trials through its dedicated volunteer recruitment website, www.flucamp.com. By volunteering to take part in one of our studies in a safe, controlled, clinical environment under expertly supervised conditions you are playing your part to further medical research and help increase the understanding of respiratory illnesses.

Individuals interested in taking part in COVID-19 human challenge study research can learn more at www.UKCovidChallenge.com.

For further information please contact:

Notes to Editors

Open Orphan plc

Open Orphan plc (London and Euronext: ORPH) is a rapidly growing pharmaceutical service/contract research company that is a world leader in testing vaccines and antivirals using human challenge clinical trials. The Company provides services to Big Pharma, biotech and government/public health organisations.

Open Orphan runs challenge studies in London from both its 19-bedroom Whitechapel quarantine clinic and its state-of-the-art 24-bedroom QMB clinic with its highly specialised on-site virology and immunology laboratory. Open Orphan has a leading portfolio of human challenge study models for infectious and respiratory diseases and is developing a number of other models. There has been an explosion in the growth of the infectious disease pharmaceuticals market, which is estimated to grow to in excess of $250bn by 2025. The Group is focused on refreshing its existing challenge models and develop new models, such as Malaria, to address the dramatic growth potential of the global infectious disease market.

Building upon its many years of challenge studies and virology research, the Company is developing an in-depth database of infectious disease progression data. Based on the Company's Disease in Motion® platform, this unique dataset includes clinical, immunological, virological and digital (wearable) biomarkers. The Disease in Motion platform has many potential applications across a wide variety of end users including big technology, wearables, pharma and biotech companies.

Open Orphan's Paris office has been providing biometry, data management and statistics to its many European pharmaceutical clients for over 20 years. For over 15 years, the Company's Netherlands office has been providing drug development consultancy and services, including CMC (chemistry, manufacturing and controls), PK and medical writing, to a broad range of European clients. Both offices are now also fully integrated with the London office and working on challenge study contracts as well as supporting third party trial contracts.